Radius of curvature of the radial head matches the capitellum: a magnetic resonance imaging analysis.

Background: The purpose of this study is to utilize elbow magnetic resonance imaging (MRI) to compare the radius of curvature (ROC) of the radial head peripheral cartilaginous rim and the cartilage contour of the capitellum to evaluate if the radial head could be a suitable osteochondral autograft for capitellar pathology. Methods: All patients who underwent an MRI of the elbow over a three-year period were reviewed. Patients with the following diagnoses were excluded: osteochondritis dissecans, osteomyelitis, tumor, and osteoarthritis. The radius of curvature of the radial head (RhROC) was measured on the axial oblique MRI sequence. The radius of curvature of the capitellum (CapROC) was measured on sagittal oblique MRI sequences, the width of the articular surface of the capitellum on coronal MRI sequences and the radial head height (RhH) and capitellar vertical height on sagittal oblique sequences. All measurements were obtained at the midpoint of the radiocapitellar joint. Spearman's coefficient was used to assess the correlation between ROC measurements. Results: Eighty-three patients were included with a mean age of 43 +/- 17 years (57 males and 26 females, 51 right and 32 left elbows). The median RhROC and CapROC measurements were 12.3 mm (interquartile range [IQR] 1.6) and 11.9 mm (IQR 1.7), respectively. The median difference was 0.3 mm (IQR = 0.6; CI 95% = [0.24, 0.46]; P < .001). A strong positive correlation was found between RhROC and CapROC (ρ = 0.89; r2 = 0.819; P < .001). Ninety-four percent (78/83) of patients had a median difference between the RhROC and CapROC of less than or equal to 1 mm, and 63% (52/83) were within 0.5 mm. The inter-rater and intra-rater reliability for RhROC and CapROC was good, intraclass correlation coefficient (ICC) = 0.89, ICC = 0.87, and ICC = 0.96, ICC = 0.97, respectively. RhH was 10.6 ± 1.3 mm, and the width of the articular surface of the capitellum was found to be 13.8 ± 1.6 mm. Conclusion: The ROC of the convex peripheral cartilaginous rim of the radial head is similar to the ROC of the capitellum. In addition, the RhH was approximately 78% of the capitellar articular width. Based on this imaging analysis, the radial head could prove to be a robust local osteochondral autograft with a similar cartilage contour in the reconstruction of the capitellum in complex intra-articular distal humerus fractures with associated radial head fractures and in the setting of "kissing lesions" of the radiocapitellar joint. Furthermore, an osteochondral plug harvested from the "safe zone" of the peripheral cartilaginous rim of the radial head could be utilized to treat isolated osteochondral lesions of the capitellum.

Autograft-Only and Allograft-Augmented Hamstring Autograft Have Similar Failure Rates After Anterior Cruciate Ligament Reconstruction.

Purpose: To compare failure rates and clinical outcomes after hamstring autograft anterior cruciate ligament (ACL) reconstruction with and without allograft augmentation by a single surgeon otherwise using the same surgical technique. Methods: This was a retrospective analysis with prospectively collected patient-reported outcomes of primary hamstring autograft ACL reconstruction with and without allograft augmentation performed in a military population by a single surgeon. The primary outcome measure was graft failure, defined as graft rupture confirmed by use of magnetic resonance imaging scans and/or revision ACL reconstruction. The secondary outcome measure was the postoperative Knee Injury and Osteoarthritis Outcome Score. Results: This study included 112 patients with a mean follow-up period of 65.3 months. In patients with a graft diameter of 8 mm or greater, there was no difference in failure rates (9.4% for autograft only vs 6.3% for hybrid, P = .59). There was a higher failure rate in patients in the autograft-only group with a graft diameter of less than 8 mm (29.4%) when compared with the hybrid graft group (6.3%, P = .008). There were no hybrid grafts less than 8 mm in diameter. There were no differences in the Knee Injury and Osteoarthritis Outcome Score between groups as long as the graft diameter was 8 mm or greater. Conclusions: In patients undergoing hamstring ACL reconstruction, there was no significant difference in graft failure rates or outcome scores between autograft only and autograft with allograft augmentation as long as grafts were 8 mm or greater. High failure rates were seen when the graft diameter was less than 8 mm. Level of Evidence: Level III, retrospective cohort study.

Progressive multifocal leukoencephalopathy with natalizumab extended or standard interval dosing in the United States and the rest of the world.

BACKGROUND: Progressive multifocal leukoencephalopathy (PML), an important identified risk for natalizumab, has been described for standard interval dosing (SID; dosing interval every-4-weeks). Information on PML with natalizumab extended interval dosing (EID; dosing interval >every-4-weeks) in the US and the rest of the world (ROW) is limited. RESEARCH DESIGN AND METHODS: A retrospective analysis of patient demographics, risk factors, clinical characteristics, and clinical outcomes was conducted on confirmed natalizumab EID and SID PML cases evaluated from Biogen pharmacovigilance systems. RESULTS: Of 857 confirmed natalizumab PML cases, EID and SID accounted for 7.5% and 92.5%, respectively (US: 12.9% and 87.1%; ROW: 5.4% and 94.6%). PML risk factors included anti-JCV index > 1.5 (US: EID, 56.7% and SID, 12.8%; ROW: EID, 44.1% and SID, 21.0%), mean duration of natalizumab treatment (US: 90.0 and 70.2 months; ROW: 54.1 and 49.8 months), and prior immunosuppressive therapy (US: 20.0% and 21.7%; ROW:11.8% and 18.0%). In the EID and SID groups, 68.8% and 76.0% of patients, respectively, were alive at up to 2 years after diagnosis. CONCLUSIONS: This analysis provides insights on PML in patients receiving natalizumab that extend current knowledge, particularly regarding PML in patients receiving natalizumab EID, which can be built upon in the future.

Use of Cryopreserved Amniotic Membrane During Pterygium Excision: Health Economic Analysis.

Purpose: To determine the health economic opportunity cost or gain associated with performing pterygium excision surgery using the TissueTuck technique with cryopreserved amniotic membrane (AM) instead of conjunctival autograft (CAU). Methods: We performed a literature review to determine the average surgical duration of pterygium surgery using CAU with fibrin glue or sutures to calculate the average time saved with the TissueTuck technique. Such time savings was then used to determine the opportunity revenue gain per national average Medicare reimbursement if adjusted to the average surgical duration of cataract surgery. Results: The time savings achieved using the TissueTuck technique over CAU with fibrin glue is 8.9 min per procedure, which can be applied to additional MSICS or phacoemulsification procedures to generate an opportunity revenue gain of $1167 or $762 per 2022 National Average Medicare reimbursement, respectively. After subtracting the current list cost of AmnioGraft (ie, $645), the opportunity gain is $522 or $117 if the time saving is applied to the above procedures, respectively. Alternatively, the time savings achieved by using the TissueTuck technique over CAU with sutures is 23.4 min per procedure, which can be applied to additional MSICS or phacoemulsification procedures to generate an opportunity revenue gain of $3068 and $2004 per TissueTuck procedure or $2423 or $1359 when accounting for the list cost of AmnioGraft, respectively. Conclusion: The TissueTuck surgical technique using cryopreserved AM for pterygium takes less time, has lower recurrence rates, and provides an opportunity gain compared to pterygium excision with CAU.

Revision Distal Biceps Tendon Repair Using Original Intramedullary Buttons.

There are several techniques used for tendon fixation in distal biceps tendon repair. Intramedullary unicortical button fixation has the advantage of high biomechanical strength, minimal proximal radial bone removal, and low risk of injury to the posterior interosseous nerve. One disadvantage in revision surgery is retained implants in the medullary canal. This article describes a novel technique for revision distal biceps repair initially fixed with intramedullary unicortical buttons, using the original implants.

Cryopreserved Amniotic Membrane Using the TissueTuck Technique: A Sutureless Approach for Pterygium Surgery.

PURPOSE: The purpose of this study was to evaluate the clinical outcomes of the TissueTuck technique in the management of pterygium. METHODS: This was a single-center, retrospective review of patients with primary or recurrent pterygium that underwent surgical excision followed by application of cryopreserved amniotic membrane (AM) using the TissueTuck technique. All patients underwent surgery between January 2012 and May 2019. Patient profile, surgical time, complications, and rates of pterygium recurrence were analyzed. RESULTS: A total of 582 eyes of 453 patients (328 female patients; 65.1 ± 13.9 years) were included for analysis and initially presented with primary (92%) pterygium. The average duration of pterygium excision surgery was 14.7 ± 5.2 minutes (median: 14, range: 4-39 minutes) with mitomycin C administration in 257 (45%) eyes. At the last follow-up of 30.2 ± 22.2 months (median: 24.5, range: 3-94 months), BCVA significantly improved from logMAR 0.23 at baseline to logMAR 0.19 ( P < 0.0001). Recurrence rate was 2.3% but only 0.7% (2/274) in those cases with primary, single-headed pterygium without mitomycin C treatment. Other postoperative complications in that cohort included granuloma (7.9%), scarring (3.8%), and diplopia in extreme lateral gaze (2.5%). The AM remained secured to the ocular surface throughout the postoperative period. CONCLUSIONS: The TissueTuck surgical technique with cryopreserved AM can be performed in minimal time and result in a low recurrence and complication rate after pterygium surgery.

Arthroscopic Anatomic Knotless Coracoclavicular Ligament Repair Without Coracoid Drilling.

Acromioclavicular joint injuries are common in young active patients. A wide variety of surgical techniques exist to address specific complications associated with surgery. Complications after surgery include loss of reduction, fracture of the clavicle or coracoid, failure of fixation, and prominent and symptomatic hardware. This technique aims to reduce these complications with an arthroscopic anatomic coracoclavicular ligament repair using knotless adjustable loop buttons with fifth-generation suture tape and no drilling of the coracoid.

Outcomes Following Modified Broström for Chronic Lateral Ankle Instability With and Without Peroneal Tendon Exploration.

BACKGROUND: It is not known how peroneal tendon exploration influences results after modified Broström for lateral ankle instability. We propose peroneal exploration at the time of modified Broström will have similar outcomes as no peroneal exploration. METHODS: A retrospective analysis was performed of patients undergoing modified Broström with and without peroneal exploration. Foot and Ankle Outcome scores and data regarding military retention were gathered and compared. RESULTS: Seventeen patients were identified in the modified Broström only cohort and 24 in the peroneal exploration cohort. Patients had mean follow-up of 5 years in both cohorts. The mean FAOS in the modified Broström only cohort was 68 and 72 in the cohort with peroneal exploration (P = .541). When each FAOS subcategory was analyzed, no difference was identified in any subcategory. Eight of 17 patients (47%) in the modified Broström only cohort remained active duty compared with 8 of 24 patients (33%) in the modified Broström with peroneal exploration cohort (P = .518). One patient medically discharged in the modified Broström only cohort versus 6 in peroneal exploration cohort (P = .109). Overall satisfaction with the procedure was 12 of 17 (71%) in the modified Broström only cohort and 19 of 24 (79%) in the peroneal exploration cohort (P = .529). CONCLUSIONS: No significant difference was identified between patients undergoing modified Broström alone or modified Broström with peroneal exploration. There was no significant difference in return to duty, medical discharge or patient satisfaction. LEVELS OF EVIDENCE: Level III: retrospective case-control study with prospectively collected data.

The Epidemiology of Meniscus Injury.

Meniscus surgery is one of the most commonly performed orthopedic procedures worldwide. Modifiable risk factors for meniscus injury include body mass index, participation in athletics and occupation. Nonmodifiable risk factors include age, sex, lower extremity alignment, discoid meniscus, ligamentous laxity, and biconcave tibial plateau. Conditions commonly associated with meniscal injury are osteoarthritis, anterior cruciate ligament injury, and tibial plateau fractures. Tear type and location vary by patient age and functional status. Surgical management of meniscus injury is typically cost-effective in terms of quality-adjusted life years. The purpose of this review is to provide an overview of meniscal injury epidemiology by summarizing tear types and locations, associated conditions, and factors that increase the risk for meniscal injury. The economic burden of meniscus injury and strategies to prevent injury to the meniscus are also reviewed.

Use and abuse of dietary supplements in persons with diabetes.

The dietary supplement industry has estimated sales of over $30 billion in the US and over $100 billion globally. Many consumers believe that dietary supplements are safer and possibly more effective than drugs to treat diabetes. The sheer volume of the literature in this space makes compiling them into one review challenging, so much so that primarily narrative reviews currently exist. By applying the interactive database supplied by the Office of Dietary Supplements at the National Institutes of Health, we identified the top 100 ingredients that appeared most often in dietary supplement products. One-hundred different keyword searches using the ingredient name and the word diabetes were performed using a program developed to automatically scrape PubMed. Each search was retained in a separate Excel spreadsheet, which was then reviewed for inclusion or exclusion. The studies that met the inclusion criteria were evaluated for effect of reducing and controlling diabetes. The PubMed scrape resulted in 6217 studies. For each keyword search only the most recent 100 were retained, which refined the total to 1823 studies. Of these 425 met the screening criteria. The ingredients, fiber, selenium and zinc had the most studies associated with improvement in diabetes. Several popular supplement ingredients (phosphorus, pantothenic acid, calcium, magnesium, glutamine, isoleucine, tyrosine, choline, and creatine monohydrate) did not result in any studies meeting our screening criteria. Our study demonstrates how to automate reviews to filter and collapse literature in content areas that have an enormous volume of studies. The aggregated set of studies suggest there is little clinical evidence for the use of dietary supplements to reduce or control diabetes.

Outcomes Following Major Oncologic Operations for Non-AIDS-Defining Cancers in the HIV Population: A Matched Comparison to the General Population.

INTRODUCTION: Human immunodeficiency virus (HIV) patients are living longer due to the availability of antiretroviral therapies, and non-AIDS-defining cancers are becoming more prevalent in this patient population. A paucity of data remains on post-operative outcomes following resection of non-AIDS-defining cancers in the HIV population. METHODS: The National Inpatient Sample was utilized to identify patients who underwent surgical resection for malignancy from 2005 to 2015 (HIV, N = 52,742; non-HIV, N = 11,885,184). Complications were categorized by international classification of disease (ICD)-9 diagnosis codes. Cohorts were matched on insurance, household income, zip code and urban/rural setting. Logistic regression assessed whether HIV was an independent predictor of post-operative complications. RESULTS: Descriptive statistics found HIV patients to have an increased rate of complications following select oncologic surgical resections. Univariate and multivariate logistic regression found HIV to only be an independent predictor of complications following pulmonary lobectomy (p = 0.011; OR 2.93, 95% CI 1.29-6.73). Length of stay was statistically longer following colectomy (2.61 days, 95% CI 1.98-3.44) in those with HIV. CONCLUSIONS: Our findings are hypothesis generating and highlight the potential safety of major cancer surgery in the HIV population. However, care providers need be cognizant of the potential increased risk of post-operative complications following pulmonary lobectomy and the potential for increased length of stay. These findings are an initial insight into quality of care and outcomes metrics on HIV patients undergoing major cancer operations.

Cardiometabolic thresholds for peak 30-min cadence and steps/day.

PURPOSE: To provide empirically-supported thresholds for step-based intensity (i.e., peak 30-min cadence; average of the top 30 steps/min in a day) and steps/day in relation to cardiometabolic health outcomes. METHODS: Receiver operating characteristic curve analysis was applied to the National Health and Nutrition Examination Survey (NHANES) 2005-2006 accelerometer-derived step data to determine steps/day and peak 30-min cadence as risk screening values (i.e., thresholds) for fasting glucose, body mass index, waist circumference, high blood pressure, triglycerides, and HDL cholesterol. Thresholds for peak 30-min cadence and steps/day were derived that, when exceeded, classify the absence of each cardiometabolic risk factor. Additionally, logistic regression models that included the influence of age and smoking were developed using the sample weights, primary sampling units (PSUs), and stratification variables provided by the NHANES survey. Finally, a decision tree analysis was performed to delineate criteria for at-risk versus healthy populations using cadence bands. RESULTS: Peak 30-min cadence thresholds across cardiometabolic outcomes ranged from 66-72 steps/min. Steps/day thresholds ranged from 4325-6192 steps/day. Higher thresholds were observed in men compared to women. In men, higher steps/day thresholds were observed in age ranges of 30-39, while in women, higher thresholds were observed in the age-range 50-59 years. Decision trees for classifying being at low risk for metabolic syndrome contained one risk-free leaf at higher cadence bands, specifically for any time accumulated at ≥120 steps/min. CONCLUSIONS: Minimum thresholds representing absence of cardiometabolic risk range from 4325-6192 steps/day and 66-72 steps/min for peak 30-min cadence. Any time accumulated at ≥120 steps/min was associated with an absence of cardiometabolic risk. Although based on cross-sectional data, these thresholds represent potentially important and clinically interpretable daily physical activity goals.

Intravenous Zanamivir in Hospitalized Patients With Influenza.

BACKGROUND: Children with severe influenza infection may require parenteral therapy if oral or inhaled therapies are ineffective or cannot be administered. Results from a study investigating intravenous (IV) zanamivir for the treatment of hospitalized infants and children with influenza are presented. METHODS: This phase II, open-label, multicenter, single-arm study assessed the safety of investigational IV zanamivir in hospitalized children with influenza. Safety outcomes included treatment-emergent adverse events (TEAEs), clinical laboratory measurements, and vital signs. Clinical outcomes, pharmacokinetics, and virologic efficacy data were collected as key secondary outcomes. RESULTS: In total, 71 children received treatment with investigational IV zanamivir (exposure comparable to 600 mg twice daily in adults). TEAEs and serious TEAEs (STEAEs) were reported in 51 (72%) and 15 (21%) patients, respectively. The mortality rate was 7%, and median durations of hospital and ICU stays were 6 and 7.5 days, respectively. No STEAEs or deaths were considered related to IV zanamivir treatment, and no patterns of TEAEs, laboratory abnormalities, or vital signs were observed. The mean zanamivir exposures from 34 patients with normal renal function who received 12 mg/kg, 14 mg/kg, or 600 mg of IV zanamivir ranged from 64.5 to 110 hour·µg/mL. The median change from baseline in the viral load was -1.81 log10 copies per mL after 2 days of treatment. CONCLUSIONS: The safety profile of IV zanamivir was favorable, with no drug-related STEAEs reported. The majority of children experienced virologic response and clinical improvement during the treatment course. Systemic zanamivir exposures in children were consistent with adults.

Adjunctive use of ezogabine/retigabine with either traditional sodium channel blocking antiepileptic drugs (AEDs) or AEDs with other mechanisms of action: Evaluation of efficacy and tolerability.

Integrated data from three double-blind, randomized, placebo-controlled trials were analyzed to evaluate the efficacy and tolerability of ezogabine (EZG; US adopted name)/retigabine (RTG; international non-proprietary name) when used in combination with ≥1 sodium channel blocking antiepileptic drug (AED), ≥1 non-sodium channel blocking AED, or ≥1 AED from both the sodium channel and non-sodium channel mechanistic groups. Efficacy and tolerability appeared to be similar across all three groups of patients.

Evaluation of the migraine treatment sumatriptan/naproxen sodium on blood pressure following long-term administration.

Anti-inflammatory and pain therapies have been associated with blood pressure (BP) destabilization. Hence, the effects on BP of sumatriptan/naproxen sodium in fixed-dose combination, sumatriptan 85 mg, and naproxen sodium 500 mg administered intermittently for the acute treatment of migraine attacks were assessed. Patients with migraine with or without aura and no history of hypertension were randomized to sumatriptan/naproxen sodium (n=135), sumatriptan (n=136), or naproxen sodium (n=136) to treat migraine attacks for 6 months in a double-blind, parallel-group trial. Following a treated migraine attack, patients performed 2 consecutive days of self-measured BPs beginning ≥24 hours after the last dose of study medication and transmitted them by a transtelephonic modem. The primary end point was the change from baseline in self-measured BP at 6 months. Changes in self-measured BP from baseline to 6 months for sumatriptan/naproxen sodium were -2.1/-1.5 mm Hg (95% confidence intervals, -3.4 to -0.8 for systolic and -2.6 to -0.3 for diastolic). Mean changes from baseline in self-measured BP did not differ among the 3 treatment groups. Additional categorical analyses did not show increases from baseline with sumatriptan/naproxen sodium relative to either of the monotherapy groups. Intermittent acute migraine treatment with sumatriptan/naproxen sodium for up to 6 months was associated with clinically insignificant decreases in self-measured BP that were similar to those with sumatriptan or naproxen alone in normotensive patients with migraine.

Adjunctive lamotrigine XR for primary generalized tonic-clonic seizures in a randomized, placebo-controlled study.

Efficacy and tolerability of once-daily adjunctive lamotrigine extended-release (XR) for primary generalized tonic-clonic (PGTC) seizures in epilepsy were evaluated. Patients (n = 153) ≥ 13 years old diagnosed with epilepsy with PGTC seizures were randomized to once-daily adjunctive lamotrigine XR or placebo in a double-blind, parallel-group trial comprising a baseline phase, a 7-week double-blind escalation phase, and a 12-week double-blind maintenance phase. Lamotrigine XR was more effective than placebo with respect to median percentage reduction from baseline in weekly PGTC seizure frequency (primary endpoint-19-week treatment phase: 75.4% vs 32.1%, P<0.0001; escalation phase: 61.9% vs 30.6%, P = 0.0016; maintenance phase: 89.7% vs 33.3%, P<0.0001). Lamotrigine XR was more effective than placebo with respect to the percentage of patients with ≥50% reduction in PGTC seizure frequency. Significant separation from placebo for ≥50% reduction in PGTC seizures was observed beginning on treatment day 8. The most common adverse event was headache (lamotrigine XR 14%, placebo 16%).

Onset of dyskinesia with adjunct ropinirole prolonged-release or additional levodopa in early Parkinson's disease.

Levodopa-induced dyskinesia can result in significant functional disability and reduced quality of life in patients with Parkinson's disease (PD). The goal of this study was to determine if the addition of once-daily ropinirole 24-hour prolonged-release (n = 104) in PD patients not optimally controlled with levodopa after up to 3 years of therapy with less than 600 mg/d delays the onset of dyskinesia compared with increasing doses of levodopa (n = 104). During the study, 3% of the ropinirole prolonged-release group (mean dose 10 mg/d) and 17% of the levodopa group (mean additional dose 284 mg/d) developed dyskinesia (P < 0.001). There were no significant differences in change in Unified Parkinson's Disease Rating Scale activities of daily living or motor scores, suggesting comparable efficacy between the two treatments. Adverse events were comparable in the two groups with nausea, dizziness, insomnia, back pain, arthralgia, somnolence, fatigue, and pain most commonly reported. Ropinirole prolonged-release delayed the onset of dyskinesia with comparable efficacy to increased doses of levodopa in early PD patients not optimally controlled with levodopa.

Incidence and time course of subsyndromal symptoms in patients with bipolar I disorder: an evaluation of 2 placebo-controlled maintenance trials.

BACKGROUND: Subsyndromal symptoms in bipolar disorder can cause significant functional impairment and are associated with relapse. METHOD: In this post hoc analysis from 2 randomized, double-blind, 18-month, placebo-controlled maintenance trials for bipolar I disorder (both trials were conducted between August 1997 and August 2001 and used DSM-IV criteria), the incidence, time course, and impact of pharmacotherapy on subsyndromal symptoms were examined. RESULTS: Subsyndromal symptoms occurred in approximately 25% of all visits. Compared with placebo (54.8%), a significantly higher mean percentage of visits in remission were observed with lamotrigine treatment (63.0%, p = .020) but not with lithium treatment (60.0%, p = .165). The median time to onset of subsyndromal symptoms for lamotrigine (N = 223), lithium (N = 164), and placebo (N = 188) was 15, 15, and 9 days, respectively. Compared with placebo, both lamotrigine and lithium significantly delayed the time from randomization to onset of subsyndromal symptoms (p = .046, lamotrigine vs. placebo; p = .033, lithium vs. placebo; p = .763, lamotrigine vs. lithium) and the time from onset of subsyndromal symptoms to subsequent mood episode (p = .037, lamotrigine vs. placebo; p = .023, lithium vs. placebo; p = .845, lamotrigine vs. lithium). Agreement between the polarities of the first-observed subsyndromal symptom and subsequent intervention for mood episode was statistically significant (p < .001). CONCLUSION: Subsyndromal symptoms are common during maintenance treatment and appear to be associated with relapse into an episode of the same polarity. Both lithium and lamotrigine delayed the onset of subsyndromal symptoms and the time from onset of subsyndromal symptoms to subsequent relapse. Further study to assess whether treatment intervention can minimize subsyndromal symptoms or prevent relapse is encouraged.

Effect of lamotrigine on cognitive complaints in patients with bipolar I disorder.

BACKGROUND: This analysis describes the effects of bipolar I disorder on self-reported neurocognitive measures and remediation of these deficits with lamotrigine therapy. METHOD: Data were derived from 2 clinical trials designed to assess the efficacy of lamotrigine as maintenance therapy for recently manic (N = 349) or depressed (N = 966) patients (DSM-IV criteria). During the 8- to 16-week open stabilization phase, patients received lamotrigine as monotherapy or as adjunctive therapy (target dose = 200 mg/day, minimum dose = 100 mg/day) while other psychotropic drugs were discontinued. The Medical Outcomes Study Cognitive Scale (MOS-Cog) and the AB-Neurological Assessment Scale (AB-NAS) were used to measure cognitive functioning at baseline and at the end of the open-label phase. To examine the relationship between depressive and manic symptomatology, initiation of lamotrigine, and cognitive functioning, correlational analyses and analyses of covariance were conducted. RESULTS: Bipolar patients in both trials had significant cognitive impairment; however, it was much greater in index episode depressed bipolar patients compared with index episode manic patients. In both studies, substitution of lamotrigine for other psychotropic medications significantly improved the mean scores from baseline to the end of the open-label phase on the MOS-Cog and the AB-NAS (p < .0001). Among patients who took lamotrigine as monotherapy, the mean MOS-Cog score also improved significantly versus baseline (+32.2, or 81%, for depressed patients, p < .0001; and +19.9, or 35%, for manic patients, p < .0001). Mean AB-NAS scores (-19.7, or -55%, for depressed patients, p < .0001; and -7.2, or -32%, for manic patients, p = .0062) showed similar improvement. Cognitive impairment was significantly correlated with depression symptom severity based on Hamilton Rating Scale for Depression scores (p < .0001). After controlling for change in mood, age, gender, baseline score, duration of illness, and duration of use of other psychotropics, a significant improvement in cognition was observed during the open-label phase when lamotrigine was used as monotherapy/adjunctive therapy. CONCLUSION: Treatment with lamotrigine as monotherapy and as adjunctive therapy was associated with improved cognitive functioning and reduced neurocognitive side effects, regardless of index mood polarity.

Assessing antipsychotic effectiveness in dementia with the factor structure of the Psychogeriatric Dependency Rating Scale (PGDRS).

OBJECTIVE: Behavioral and psychological symptoms of dementia (BPSD) impact patient functioning, caregiver burden, and transition to structured living environments. The purpose of this study was to use the derived factor structure of the Psychogeriatric Dependency Rating Scale (PGDRS) to retrospectively assess short-term antipsychotic effectiveness. SETTING AND MEASUREMENT: A principal components factor analysis was conducted with PGDRS admission ratings for a large national sample of hospitalized dementia patients (N = 2747). Changes in calculated factor scores (admission to discharge) were used to compare effectiveness for a subset of patients treated with one of three antipsychotic agents: haloperidol, olanzapine, or risperidone. RESULTS: A four-factor solution accounted for almost 60% of rating variance. Factors were interpreted as disruptive overactivity, thought/communication disorder, interpersonal aggressiveness, and destructiveness. Medication effects (adjusting for group differences) were found for only the Interpersonal Aggressiveness factor. Improvement in this factor score was significantly greater in the olanzapine group. CONCLUSIONS: Findings suggest that these four PGDRS factors can provide a useful framework for symptom assessment and for targeted treatment.